indomethacin
INDOMETHACIN CAPSULES
Approved
Approval ID
129eaf3a-b013-4b29-a58f-1565f9f41d5b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
indomethacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1005
Application NumberANDA090403
Product Classification
M
Marketing Category
C73584
G
Generic Name
indomethacin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (12)
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
INDOMETHACINActive
Quantity: 25 mg in 1 1
Code: XXE1CET956
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
indomethacin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1004
Application NumberANDA090403
Product Classification
M
Marketing Category
C73584
G
Generic Name
indomethacin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2023
FDA Product Classification
INGREDIENTS (12)
INDOMETHACINActive
Quantity: 50 mg in 1 1
Code: XXE1CET956
Classification: ACTIB
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6B
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT